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Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 Doncaster and Bassetlaw Area Prescribing Committee Shared Care Protocol for the Management of Pseudomonas aeruginosa Colonisation in Non-Cystic Fibrosis Adult patients with Bronchiectasis (Unlicensed Indication) 1.0 INTRODUCTION This protocol sets out guidelines for the assessment and treatment of patients who require medication for the prophylactic control of confirmed Pseudomonas aeruginosa infection in patients diagnosed with bronchiectasis. These patients are at risk of repeated hospital admission due to infective exacerbations of their bronchiectasis and the guidelines outline the responsibilities when care for the patient is to be shared between Primary Care and Respiratory Specialists. In isolated cases, patients with COPD may require similar treatment. Shared Care Protocols are intended to provide clear guidance to General Practitioners (GPs) and hospital prescribers regarding the procedures to be adopted when clinical (and therefore prescribing and financial) responsibility for a patient’s treatment with a shared-care disease is transferred from secondary to primary care. GPs, as independent contractors, have the right to decline to take clinical and prescribing responsibilities for a patient on their medical list who is being treated elsewhere. However the reason for this action must be documented. In the view of the Doncaster & Bassetlaw APC, it would be the exception for a GP to refuse to take clinical and prescribing responsibilities for an individual drug, where shared care guidelines for that drug have become common practice and where shared care guidelines include adequate support, education, and information as approved by the Doncaster & Bassetlaw APC. If a specialist asks a GP to prescribe in relation to this disease the GP should reply to this request as soon as practicable. The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequence of its use. 1 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 Traffic light system classification Green AmberA RedR G Drug Class Polymixin antibiotic Aminoglycoside antibiotic Nebulised Colistin Nebulised Tobramycin G – Prescribing initiated and retained In Primary Care A – Prescribing initiated by specialist and passed to primary care when dose effective and stable – monitoring shared as specified in SCP R – Prescribing initiated and retained by specialist – Prescribing monitoring performed in secondary care This shared care protocol applies only for the indication for which the drugs are stated to be used for. It should not be used for other indications listed on the Doncaster & Bassetlaw APC traffic light system or for other unlicensed indications for the drug. 2.0 BACKGROUND INFORMATION Pseudomonas aeruginosa is a pathogen that causes severe lung damage in patients who become colonised and subsequently chronically infected. Patients with cystic fibrosis and bronchiectasis are at risk of significant morbidity and mortality from the damage caused by this pathogen. Nebulised antipseudomonal antibiotic treatment has shown to improve lung function, slow the rate of respiratory decline and reduce the frequency of infective exacerbations and hospital admissions. The 2010 BTS guidelines recommend the use of long term nebulised antibiotics for bronchiectasis patients with proven colonisation with Pseudomonas aeruginosa who have had ≥ 3 exacerbations requiring antibiotic treatment in the last 12 months or those patients who have had fewer exacerbations that are causing significant morbidity. The advantages of nebulised antibiotics include obtaining high local concentrations with low systemic absorption and corresponding toxicity in comparison with intravenous antibiotics. Nebulised colistin and tobramycin is off-license when used in the treatment of pseudomonal infection in adult patients with bronchiectasis. 3.0 DIAGNOSIS & INVESTIGATIONS Confirmed Pseudomonas aeruginosa in sputum culture in patients with repeated exacerbations of bronchiectasis requiring intravenous antibiotics and hospital admission. Preferably, sensitivities to colistin / tobramycin should be reported prior to prescribing. Colistin should be used in preference to tobramycin wherever possible due to cost. 2 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 4.0 Drug Treatment For contraindications or further information please see the current BNF http://www.bnf.org.uk/bnf/bnf/current/index.htm or summary of product characteristics for the individual drug http://www.medicines.org.uk/ Drug, dose & TLS listing Adverse effects Therapeutic Consultant monitoring GP Clinically relevant drug interactions Baseline Sputum culture positive for Pseudomonas aeruginosa Spirometry Initial test dose with preand post dose spirometry Review at 3 months Annual Spirometry Ongoing Side effects Symptom control Report any adverse reactions to the specialist and CSM 1. Antibacterials 1.1 Colistin [Amber] Treatment (by inhalation) of Pseudomonas aeruginosa lung infection in patients with bronchiectasis BY INHALATION OF NEBULISED INJECTION: ADULT over 12 years, 12 million units every 12 hours. Usual dose is 1 million units twice daily. Sore throat or mouth which may be due to Candida albicans infection or hypersensitivity Coughing or bronchospasm which may be prevented or treated with a beta-2 agonist (see section 4.1) Perioral and peripheral parasthesia (neurotoxic side effects) – rare. NOTE: COLOMYCIN INJECTION (DISSOLVED IN 2 – 4ML WATER OR SODIUM CHLORIDE 0.9%) MAY BE USED FOR NEBULISATION GP 1.2 Tobramycin (Tobi / Bramitob) [Amber] 3 This Document will be reviewed in the light of new or emerging evidence or by October 2015. There are no known drug interactions with systemic medications due to negligible transpulmonary absorption Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 Treatment (by inhalation) of Pseudomonas aeruginosa lung infection in patients with bronchiectasis BY INHALATION OF PROPRIETARY NEBULISER SOLUTION: ADULT over 12 years, 300mg every 12 hours. Voice alteration (including hoarseness), increased cough, pharyngitis Coughing or bronchospasm which may be prevented or treated with a beta-2 agonist (see section 4.1) Tinnitus or hearing loss (rare, but must report) Baseline Sputum culture positive for Pseudomonas aeruginosa Confirmed sensitivies to tobramycin Spirometry Initial test dose with preand post dose spirometry Renal function Review at 3 months Annual Spirometry Annual Renal function Ongoing Side effects Symptom control Report any adverse reactions to the specialist and CSM 4 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Concurrent and/or sequential use with other nephrotoxic or ototoxic drugs should be avoided. Some diuretics can enhance aminoglycoside toxicity. Do not administer concomitantly with furosemide, urea or mannitol No interactions have been noted with inhaled corticosteroids, beta agonists, mucolytics and other oral and parenteral antipseudomonal antibiotics Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 4.1 ADDITIONAL INFORMATION Colistin Bronchospasm can occur. The initial test dose must be given under supervision with pre- and post-dose spirometry to assess tolerability. In the event that bronchospasm does occur, this can be relieved by the administration of a bronchodilator prior to nebulisation. For those patients that require pre-treatment with nebulised salbutamol 2.5mg, this can be mixed directly with colistin (immediately prior to use) and nebulised 1. Bronchospasm can also be associated with the hypertonicity of the colistin solution. In these instances, the colistin can be diluted with 4ml sodium chloride 0.9% (instead of 2.5ml) or with water for injections as an alternative. If there is a continued problem despite dilution and administration of a bronchodilator then treatment should be withdrawn. Diluents for Colistin The diluent can be either water for injections or sodium chloride 0.9%. The preferred option is to prescribe a 2.5ml Sodium Chloride 0.9% nebule as the use of plastic ampoules avoids the need for needles and syringes and reduces the risk of breaking glass ampoules. Choice of preparation Generic Colistin injection can be nebulised safely (off-licence use) and compares favourably with the cost of the ready prepared colomycin nebules. Colistin injection should be used wherever possible. Filters Filters are not recommended provided the patient nebulises alone in a well ventilated room or vents the nebuliser via elephant tubing. If a patient wants to use filters they may be purchased by the patient direct from PARI Medical Limited. It is recommended that pets are not present in the room when nebulisation occurs. Tobramycin Bronchospasm can occur. The initial test dose must be given under supervision with pre- and post-dose spirometry to assess tolerability. In the event that bronchospasm does occur, this can be relieved by the administration of a bronchodilator prior to nebulisation. Where patients are receiving several different respiratory therapies it is recommended that they are taken in the following order: bronchodilator, other inhaled medicinal products and then tobramycin Tobramycin is available as a specific nebuliser solution. Tobramycin should only be used if colistin treatment fails, the patient is allergic / intolerant to colistin or sensitivities preclude the use of colistin first line. Due to the difficulties associated with dilution and preparation of the dose, tobramycin 5 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 injection should NOT be used for nebulisation. The pre-prepared nebules are cost-effective alternatives to using the injections. Either Tobi or Bramitob can be used and the brand will be specified by the initiating secondary care specialist at the point of prescribing. Filters are not recommended provided the patient nebulises alone in a well ventilated room or vents the nebuliser via elephant tubing. If a patient wants to use filters they may be purchased by the patient direct from PARI Medical Limited. It is recommended that pets are not present in the room when nebulisation occurs. 5.0 SHARED CARE ARRANGEMENTS Once a stable medication regime has been established (usually 3 months), physical monitoring and prescribing of amber category drugs can be transferred to primary care with agreement. 5.1 Aspects of care for which Secondary Care Team is responsible Diagnosis and assessment of Pseudomonal infection Initiation of prescription of colistin / tobramycin by respiratory specialist registrar or above Test dose of colistin / tobramycin with pre- and post dose spirometry Supplying initial 3 month supply of treatment including diluents (and bronchodilators) required Provision of suitable nebuliser system and compressor Maintenance of suitable nebuliser / compressor system Patient / family education on the use of the nebuliser Inform the patient / carer of the potential risk to unborn foetuses during nebulisation. Exposure to carers during nebulisation should be minimised. Ensure patient is fully informed of potential benefits and side effects of treatment Ensure that shared care arrangements are in place before transfer of treatment That the patient/carer is clear what is being monitored and by whom That the patient knows what significant adverse effects/events to report urgently and to whom they should report (specialist or GP) Writing to the GP after clinic detailing whether the medication regime should remain the same, be changed or be stopped. Specify any dose or frequency changes. Monitor side effects of medication. 6 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 5.2 Monitor patient’s response to treatment during first test dose and initiation period Continue to supply colistin / tobramycin plus diluents (and bronchodilators if required) until such time that care is transferred to primary care Review patient 3 months after initiation to assess response and tolerability before shared care is initiated Report adverse events via the Yellow Card reporting system in the BNF or at www. Yellowcard.gov.uk Aspects of care for which Primary Care Team is responsible Ensure that shared care arrangements are in place before transfer of treatment That the patient/carer is clear what is being monitored and by whom That the patient knows what significant adverse effects/events to report urgently and to whom they should report (specialist or GP) When the specialist initiates treatment, reply to the request for shared care as soon as practicable Prescribe colistin / tobramycin (and bronchodilators if required) and diluents required. Continued prescribing is appropriate for patients attending specialist review Amend prescription as per requests from secondary care for dose changes in patients on established treatment Seek specialist advice promptly as advised in the shared care protocol or if signs/symptoms of changes occur Report adverse events via the Yellow Card reporting system in the BNF or at www. Yellowcard.gov.uk and to the consultant sharing the care of the patient Stop treatment on advice of specialist, or immediately if intolerable side effects occur provided that it is safer to do so than to continue this therapy 5.3 Patient (or Carer’s) Responsibilities Discuss potential benefits and side effects of treatment with the specialist and GP. Identify whether they have a clear picture of these from the specialist and to raise any outstanding queries Share any concerns they have in relation to treatment with the medicine Report any adverse effects to their specialist or GP whilst taking the medicine Report to the specialist or GP if they do not have a clear understanding of their treatment 7 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 Participate in the monitoring of therapy and the assessment of outcomes, to assist health professionals to provide safe, appropriate treatment 8 This Document will be reviewed in the light of new or emerging evidence or by October 2015. Doncaster & Bassetlaw Area Prescribing Committee Approved October 2010 V1.0 6.0 PROCEDURE FOR ADOPTING SHARED CARE 6.1 General Procedure: The specialist will send to the GP a diagnostic assessment report, a copy of the shared care protocol and a shared care referral specifying who is responsible for monitoring. Both the specialist and GP should sign the proforma with a record kept in the GP and specialist records. Full details will be given of the prescribing regime (brand, form, strength and dose of medication) and follow-up plan. The patient will be asked to make arrangements with their GP for continued supply. 7 .0 REFERENCES 1. Roberts GW., Badcock NR., Jarvinen AO., 1992. Cystic fibrosis Inhalation Therapy: Stability of a combined Salbutamol / Colistin Solution. Australian Journal of Hospital Pharmacy. 22(5): 378-80 British National Formulary September 2010 Summary of Product Characteristics: Colomycin Injection. Forest Laboratories UK Limited. British Thoracic Society. Nebuliser treatment best practice guidelines. Thorax. 1997 Vol 52 suppl 2. British Thoracic Society. Guideline for non-CF bronchiectasis. Thorax. 2010 Vol 65 suppl 1. Summary of Product Characteristics: Bramitob Nebuliser Solution. Chiesi Ltd. 05/08/2009 Summary of Product Characteristics: Tobi Nebuliser Solution. Novartis Pharmaceuticals UK Ltd. 28/09/2006 11.0 Shared Care Development Written By: Dr Martin Highcock, Consultant Respiratory Physician Dr Helen Meynell Consultant Pharmacist Doncaster Royal Infirmary Doncaster & Bassetlaw Area Prescribing Committee October 2010 9 This Document will be reviewed in the light of new or emerging evidence or by October 2015.